Supervisory management board of dispatch country medicines and chemical reagents released Chinese net finance and economics recently on June 26 the announce of result of supervisory sampling observation of national medical apparatus and instruments (the 4th) (2018 the 47th) .
Control government to enhance quality of medical apparatus and instruments, use safety of product of safeguard medical apparatus and instruments is effective, total bureau of supervisory government of medicines and chemical reagents of former state provision organizes pair of metal spicula, nerve and muscle stimulation implement, 9 breed such as optometry appearance 329 batches (stage) the product undertook quality supervises sampling observation, in all 50 batches (stage) the product does not accord with a standard to set. Particular case announcement is as follows:
Be notted agree with to combine the product of medical apparatus and instruments that the standard provides by sampling observation project, 8 variety that involve 26 companies 31 batches (stage) . Specific for:
(One) nerve and muscle are exciting implement 12 enterprises 15 products. The main and collateral channels of intermediate frequency of a computer that limited company of development of science and technology of medical apparatus and instruments produces connects remedial apparatus (trade name: The number is muti_function remedial appearance) , patient connector does not accord with a standard to set; 1 when limited company of science and technology of electron of day Shui Qinghua produces muti_function the ion of 1 Taichun frequency that institute of instrument of small loose medical treatment produces remedial appearance, Nanjing guides remedial appearance, the accuracy of working data does not accord with a standard to set; 1 when without Xi Zhongde production limited company of medical apparatus and instruments produces muti_function chance of intermediate frequency cure, closedown of the accuracy of working data, output does not accord with a standard to set; The pulse of 1 Taichun frequency that without Xi Zhongde production limited company of medical apparatus and instruments produces is treated machine, output closedown does not accord with a standard to set; The computer of 1 Taichun frequency that limited company of technology of electron of Henan thousand benefit produces treats appearance, the accuracy of data of accompanying documents, power input, job does not accord with a standard to set; The intermediate frequency of a computer that profit is industrial company produces Guangzhou abundant treats appearance, connector of accompanying documents, patient, accompanying documents does not accord with a standard to set; The appearance of cure of 1 Taichun low frequency that necrotic institute produces head of femur of Beijing emperor city, Beijing circle in the air bead of sea of the appearance of diathermy of 2 Taichun frequency that limited company produces plant of cloud electron facility, Beijing 3 especially the 1 Taichun frequency that electronic technology institute produces treats appearance, accompanying documents does not accord with a standard to set; The low frequency of series of a KD that limited company of equipment of medical treatment of Jiangsu Fu Lin produces treats appearance, the accuracy of data of accompanying documents, job does not accord with a standard to set.
(2) medical and supersonic atomizer an enterprise a product. Er of saddle hill shellfish thinks of 1 when limited company of science and technology produces medical and supersonic atomizer, rate of the biggest pulverization does not accord with a standard to set.
(3) dilator of vagina of one-time use asepsis 3 enterprises 3 batch product. The 1 batch that limited company of medical apparatus and instruments of Jiangsu Kang Bao produces is one-time dilator of use asepsis vagina, allowance of incomplete of annulus oxygen ethane does not accord with a standard to set; The 100 million 1 batch of Wu Jiang city that produces into limited company of medical apparatus and instruments is one-time dilator of use asepsis vagina, structural intensity does not accord with a standard to set; The 1 batch that limited company of medical and wholesome things produces Nanchang city health clean is one-time dilator of use asepsis vagina, fight be out of shape ability, asepsis does not accord with a standard to set.
(4) transfer pump (syringe pump, demulcent pump, insulin pump) 3 enterprises 4 products. A 3 drop that produce with biology project Inc. note Jiangsu 2 electrons that Inc. of medical treatment science and technology produces Beioute are defeated by spray pump, Nanchang note pump, can listen to alarm signal not to accord with a standard to set; A transfer pump that limited company of science and technology of medical treatment of luck of Guangzhou Europe riverside produces, power input does not accord with a standard to set.
(5) medical aerobic concentrator (medical the machine that make oxygen) 5 enterprises 5 products. 1 each when limited company of limited company of equipment of medical treatment of Jiangsu Fu Lin, science and technology of facilities of gas of Jiangsu Hao Tai produces medical the machine that make oxygen, oxygen chroma does not accord with a standard to set; 1 when limited company of equipment of healthy of huge trade of red in relief city produces medical molecular sieve makes oxygen machine, of crust close gender, need not the security of the hood that the tool can open and door, overall crust security does not accord with a standard to set; 1 when limited company of medical apparatus and instruments produces peaceful Bojili medical molecular sieve makes oxygen machine, power input does not accord with a standard to set; Jiangsu double 1 when fill production of limited company of medical apparatus and instruments machine that make oxygen, outlet pressure does not accord with a standard to set.
(6) face of oral cavity jaw is panoramic X route aircraft an enterprise a product. Soredex, the oral cavity of a digitlization that PaloDEx Group Oy produces is panoramic X ray machine [procuratorial: Cheng Bang blocking tile (Shanghai) ] of limited company of dentistry medical apparatus and instruments, all ready sex does not accord with accompanying documents standard regulation.
(7) metallic spicula an enterprise 1 batch product. The spicula of 1 batch metal that Inc. of science and technology of medical treatment of Er of Jiangsu Ai Di produces, exterior surface roughness does not accord with a standard to set.
(8) high potential treats equipment an enterprise a product. The high potential of a low frequency that limited company of electron of dimension of Guangzhou abstruse division produces is treated machine, indicator light and pushbutton, accompanying documents does not accord with a standard to set.
Be notted agree with to combine the product of medical apparatus and instruments that the standard provides for the project such as label label, manual by sampling observation project, 6 variety that involve 16 companies 23, specific for:
(One) nerve and muscle are exciting implement 5 enterprises 8 products. The main and collateral channels of 2 computer intermediate frequency that limited company of development of science and technology of medical apparatus and instruments produces connects remedial apparatus (trade name: The number is muti_function treat appearance) connect remedial appearance, Beijing with main and collateral channels of intermediate frequency of a computer the pulse of a low frequency that company of hi-tech of medical apparatus and instruments of appearance, Shanghai produces the diathermy of 2 computer intermediate frequency that limited company of friendly medical apparatus and instruments produces auspicious Yunjia treats appearance, Shenyang always forest 1 what limited company of medical apparatus and instruments produces, the exterior mark of equipment or equipment component does not accord with a standard to set.
(2) medical and supersonic atomizer an enterprise a product. Saddle hill steel 1 when limited company of medical apparatus and instruments produces supersonic atomizer, the exterior mark of equipment or equipment component does not accord with a standard to set.
(3) medical aerobic concentrator (medical the machine that make oxygen) 5 enterprises 8 products. 2 when Sichuan loves limited company of science and technology to produce greatly medical the machine that make oxygen, Jiangsu pair city of 3 when fill production of limited company of medical apparatus and instruments machine that make oxygen, Yantai 1 when limited company of medical apparatus and instruments produces Kangbeier medical molecular sieve is made, exterior mark does not accord with a standard to set.
(4) optometry appearance 3 enterprises 4 products. An optometry appearance that TOPCON CORPORATION produces [procuratorial: Ma of Ao Tengsai case (China) group limited company] , the 2 optometry appearance that baud company produces (procuratorial: Limited company of trade of Shenzhen city new world) , the appearance of optometry of a computer that limited company of development of optical science and technology produces peaceful Bofaliao, exterior mark does not accord with a standard to set.
(5) face of oral cavity jaw is panoramic X route aircraft an enterprise a product. Soredex, the oral cavity of a digitlization that PaloDEx Group Oy produces is panoramic X ray machine [procuratorial: Cheng Bang blocking tile (Shanghai) limited company of dentistry medical apparatus and instruments] , operation instruction handbook does not accord with a standard to set.
(6) high potential treats equipment an enterprise a product. MARUTAKATECHNO Co. , ltd. A potential of production treats appearance (procuratorial: Beijing luck gives birth to) of content technology limited company together rather, operation instruction handbook does not accord with a standard to set.
Do not accord with a standard to provide a product to what discover in afore-mentioned sampling observation, total bureau of supervisory government of medicines and chemical reagents of former state provision already asked enterprise seat is provincial supervisory management department of food medicines and chemical reagents supervises and urge relevant enterprise according to " medical apparatus and instruments monitors regulation " " recall of medical apparatus and instruments runs way " wait for code the product that regulations asks not to accord with a standard to set to sampling observation undertakes the risk is evaluated, determine recall level according to the serious degree of blemish of medical apparatus and instruments, active recall product publishs recall information. In the meantime, the enterprise should find out a product as soon as possible unqualified reason, make rectify and reform measure and rectify and reform on schedule reach the designated position, about deal with circumstance on July 18, 2018 forward the society is announced, seasonable will relevant circumstance reports to seat provincial food medicines and chemical reagents supervises management department.
Supervisory management department of provincial food medicines and chemical reagents answers enterprise seat relevant enterprise undertakes investigating handling, undertake to the enterprise product recall, unqualified reason is investigated, fulfil rectify and reform the circumstance such as measure and public exposure information to undertake supervisory; The product causes harm to perhaps evidence proves the likelihood endangers human body health to human body, should accept suspension lawfully production, manage, use urgent control measure; Need suspends an import, answer to sign up for national medicines and chemical reagents in time to supervise management board to make administration handle a decision. The enterprise did not fulfil afore-mentioned requirements by the requirement, supervisory management department of provincial food medicines and chemical reagents should investigate seat gravely lawfully. Concerned information should be made public in time to the society.
Above fulfils a circumstance each, medicines and chemical reagents of relevant and provincial food supervises management department to control management board at medicines and chemical reagents of nation of the report before July 24, 2018.
